Technology Enhanced Behavioral Activation Treatment for Substance Use
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Substance-Related Disorders
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 206
- Locations
- 2
- Primary Endpoint
- Timeline Followback (TLFB)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to:
- test the effect of a smartphone enhanced LETS ACT (LETS ACT-SE) on frequency of substance use
- use functional magnetic resonance imaging (fMRI) to test the relationship between neuromarkers of reward sensitivity on frequency of substance use.
Detailed Description
Comorbid substance use disorder (SUD) and depression is highly prevalent and associated with elevated rates of post treatment relapse to substance use, HIV risk behavior, and associated poor mental and physical health outcomes. Further, rates of substance use and depression disproportionately affect minority groups and those living in poverty. Although efficacious, the often complex, specialized nature of CBT poses problems in its integration into substance use treatment programs. Budget cuts for mental health and substance use treatment both nationally and in the state of North Carolina, reduce availability of publically funded treatment programs and staff to patient ratios. To address this limitation, a behavioral activation (BA) treatment, the Life Enhancement Treatment for Substance Use (LETS ACT), was developed to treat depressive symptoms among a predominantly African American sample of low income illicit drug users currently receiving residential substance use treatment. Collectively, two Stage I studies and 1 year follow-up data from the investigators Stage II R01DA026424 indicate that compared to a control condition, LETS ACT is associated with significantly better outcomes for treatment retention, post treatment abstinence, HIV sexual risk behavior, depressive symptoms, and environmental reward. Although these strong outcomes suggest that LETS ACT may be ready for a Stage III dissemination trial, it is of note that there was a significant indirect effect of LETS ACT homework compliance on post treatment substance use and HIV sexual risk behavior via the theoretically proposed BA mechanism of action, environmental reward. In the context of limited access to care, these findings point to the need to identify cost-effective delivery-vehicles to increase treatment engagement outside of clinician sessions. Further, identifying neuroscience based biomarkers (neuromarkers) underlying key theoretical aspects of BA (i.e., reward sensitivity), and their relation to heterogeneity in BA treatment response among substance users with depression, are critical for the identification of accurately targeted interventions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Between 18 and 55
- •Meet criteria for DSM-V substance use disorder
- •Elevated depressive symptoms (BDI ≥ 14)
Exclusion Criteria
- •Limited mental competency (MMSE \< 23)
- •Psychosis
- •The use of psychotropic medication for \< 3 months
- •The inability to give informed, voluntary, written consent to participate
Outcomes
Primary Outcomes
Timeline Followback (TLFB)
Time Frame: TLFB will be assessed from baseline to a 12-month follow up period.
The Time Line Follow Back is a self-report measure of drug and alcohol use.
Secondary Outcomes
- Behavioral Activation for Depression Scale (BADS)(BADS will be assessed from baseline to a 12-month follow up period.)
- Reward Probability Index (RPI)(RPI will be assessed from baseline to a 12-month follow up period.)
- Beck Depression Inventory-II (BDI-II)(BDI-II will be evaluated from baseline to a 12-month follow up period)
- Daily Goals Form(Baseline to a 3-months post treatment.)
- Texas Christian University (TCU) HIV/AIDS Risk Assessment Form(TCU will be assessed from baseline to a 12-month follow up period.)
- Urinalysis(Urinalysis is assessed from post treatment to a 12-month follow up period)
- Short Form Health Survey (SF-12)(SF-12 will be assessed from baseline to a 12-month follow up period.)
- Breathalyzer(Breathalyzer will be assessed from baseline to a 12-month follow up period.)